Medication info

Bonavis Injection (Ibandronate Sodium Monohydrate)

Prescription medicationInjections정맥
Ingredient · strength
Ibandronate Sodium Monohydrate›3.375mg / 1 prefilled syringe
Manufacturer / importer
(주)팜젠사이언스
Appearance
It is an injection in a colorless and transparent solution contained in a colorless and transparent glass prefilled syringe with a single-use injection needle attached.
Packaging
3ml x 1 vial
Approval status
Active

MFDS item code 201800259 · Notified 2018.01.18 · Insurance code 670104201

Summary

Main use
Improvement of postmenopausal osteoporosis
Who receives it
Adults
Adult administration
A dose of 3mg is administered intravenously every 3 months over 15 - 30 seconds. Patients are advised to take calcium and vitamin D as supplements. If a scheduled dose is missed, administer it as soon as possible and continue the regular dosing schedule at 3-month intervals.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

Improvement of postmenopausal osteoporosis

  • Osteoporosis
View approved original text

This medication is used for the treatment of osteoporosis, which often occurs in women following menopause. Osteoporosis is a condition where bones become weak and the risk of fractures increases. This medication helps to increase bone strength and improve bone density. By doing this, it reduces the risk of fractures and helps maintain a healthy bone condition.

How it is given

Adult administration

A dose of 3mg is administered intravenously every 3 months over 15 - 30 seconds. Patients are advised to take calcium and vitamin D as supplements. If a scheduled dose is missed, administer it as soon as possible and continue the regular dosing schedule at 3-month intervals.

Precautions

This medication must only be administered via intravenous injection, and extreme caution must be taken if improperly administered near arteries or veins to avoid tissue damage. This medication should not be used in patients with a known allergy to it or its ingredients, or in patients with untreated hypocalcemia. Possible side effects during treatment include gastritis, diarrhea, abdominal pain, dyspepsia, nausea, constipation, etc., many of which are mild to moderate and often do not require discontinuation of treatment. Muscle pain, joint pain, headaches, rashes, fatigue, flu-like symptoms have also been reported, and flu-like symptoms may particularly occur during the initial phase of injection. Rarely, long-term use of this medication may result in osteonecrosis of the jaw; hence, it is important to conduct dental screening prior to administration and to avoid excessive dental treatment during therapy. If there is ear pain or discharge, the possibility of osteonecrosis of the external auditory canal should be considered. This medication may cause bone, joint, and muscle pain, and if pain is severe after administration, it is essential to consult with healthcare professionals. Atypical fractures may occur in the femur and other bones, so prompt evaluation should occur if there is pain in the thigh or groin. Pregnant or nursing women are advised not to use this medication due to lack of confirmed safety. This medication may affect kidney function, thus regular check-ups are necessary for patients with renal disease or those taking medications affecting the kidneys. In case of overdose, hypocalcemia, hypophosphatemia, etc., may occur, requiring rapid treatment and monitoring; dialysis may not be effective. This medication should not be mixed with a calcium-containing solution and must only be given as an intravenous injection. Used injection needles and syringes should not be reused and should be disposed of safely.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, facial swelling/edema, anaphylactic reactions/shock, exacerbation of asthma, Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, acute renal failure, multiple organ failure, death, fractures, osteonecrosis of the jaw, osteonecrosis of the external auditory canal, hypersensitivity reactions, vascular anomalies, phlebitis/thrombophlebitis, optic neuropathy, lower motor neuron lesions, tremors

Mild side effects

  • Gastritis
  • diarrhea
  • abdominal pain
  • dyspepsia
  • nausea
  • constipation
  • musculoskeletal pain
  • joint pain
  • muscle pain
  • flu-like illnesses
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  • fatigue
  • headaches
  • rashes
  • bone pain
  • weakness
  • injection site reactions
  • lower back pain
  • dizziness
  • loss of appetite
  • bone pain
  • insomnia
  • anxiety
  • tinnitus
  • hearing loss
  • hypothyroidism
  • lipomas
  • ocular hemorrhage
  • heart failure
  • urinary disorders
  • hematuria
  • skin exfoliation
  • hyperventilation
  • coughing
  • laryngitis
  • vaginitis
  • symptoms of menopause

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container to prevent exposure to air or moisture, ideally at room temperature between 1 and 30 degrees Celsius. Such storage helps to maintain the effectiveness of the medication.

Appearance and packaging

Appearance

It is an injection in a colorless and transparent solution contained in a colorless and transparent glass prefilled syringe with a single-use injection needle attached.

Package unit

3ml x 1 vial

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.